A Multicenter Retrospective Review to Evaluate the Feasibility of Dye Marking Using the Ion Endoluminal System

Completed

• Conditions: Lung Cancer
• Interventions: Device: Ion Endoluminal System

• Registration Number: NCT05546437
• Lead Sponsor: Intuitive Surgical

Brief Summary

The overall objective of this study is to assess the ability of the Ion Endoluminal System to perform pleural based tissue dye marking in anticipation of a lung resection.

Detailed Description

This study is a retrospective multicenter chart review of patients who underwent a pleural based tissue dye marking with the Ion Endoluminal System in anticipation of lung resection. The aim of the study is to assess the feasibility of the Ion Endoluminal System to perform pleural based tissue marking. As this is a retrospective study, the Ion dye marking procedure will have been performed according to the physician's standard technique. All consecutive cases in which a dye marking procedure was attempted and/or completed with the Ion Endoluminal System will be included.

Study Timeline

• Study Start: 2022-07-22
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-16
• Study First Posted: 2022-09-19
• Primary Completion: 2023-04-30
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 288

Inclusion Criteria

• Subject is 18 years or older at the time of the procedure.
• Dye marking attempted/performed using the Ion Endoluminal Platform

Read More

Exclusion Criteria

• Resection not performed following dye marking procedure

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Ion Endoluminal dye marking of pulmonary nodule for resection	Ion Endoluminal System	Subjects in which a pulmonary lesion dye marking procedure was attempted or performed with the Ion Endoluminal System in anticipation of resection of the lesion

Primary Outcome Measures

Name	Time	Method
Successful dye injection	Intra-procedure through the release of the final pathology report, approximately 3 days post-procedure	The ability of the investigator to localize the marked lesion during resection, assessed by successful injection of dye, localization of due within the targeted area, and the ability to visualize the dye marking intra-operatively or on resected sample
Pneumothorax	Intra-procedure	Incidence of all pneumothoraces related to the Ion procedure

Secondary Outcome Measures

Name	Time	Method
Adverse events	Intra-procedure until the start of the resection procedure	All adverse events related to the Ion procedure
Operative time	Intra-operative	Time from start of resection procedure to end of resection procedure (skin-to-skin time)
Procedure time	Intra-procedure	Time from start of Ion dye marking procedure (defined as when the Ion catheter crosses the endotracheal tube \[ETT\]) to end of Ion dye marking procedure (defined as when the Ion catheter leaves the ETT).
Type of resection planned and performed	Intra-operative	The type of resection procedure planned (ex., lobectomy, wedge resection) and whether that plan was altered after the dye marking procedure or resection has started.
Conversion to alternate approach or termination of procedure due to localization issues	Intra-operative	Rate of resections converted to an alternative approach or terminated. Conversion is defined as a change in the procedural approach (either a different technology \[ex., open resection\] after the resection procedure has started. Termination is defined as prematurely ending the operation before the resection has been performed.

Trial Locations

Locations (1)

Orlando Health; 🇺🇸 Orlando, Florida, United States